Professional Certificate in Medical Device Regulatory Compliance Basics
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Compliance Basics is a crucial course designed to meet the growing industry demand for professionals with a solid understanding of regulatory requirements. This program focuses on imparting essential skills and knowledge required to navigate the complex regulatory landscape of medical devices.
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Here are the essential units for a Professional Certificate in Medical Device Regulatory Compliance Basics:
● Introduction to Medical Device Regulations: An overview of the legal and regulatory landscape for medical devices, including primary and secondary legislation, and key regulatory bodies.
● Medical Device Classification: Understanding the risk-based classification system for medical devices and how it impacts regulatory requirements.
● Quality Management Systems (QMS): An introduction to QMS, including ISO 13485 and its role in ensuring regulatory compliance.
● Clinical Evaluation and Investigations: Exploring the requirements for clinical evaluation and clinical investigations, including the preparation of Clinical Evaluation Reports (CERs).
● Technical File Preparation: Learning how to prepare and maintain a technical file for medical devices, including the requirements for labeling and instructions for use.
● Clinical Trials and Post-Market Surveillance: Understanding the regulatory requirements for clinical trials and post-market surveillance, including the reporting of adverse events.
● Medical Device Marketing and Advertising: Learning the regulatory requirements for marketing and advertising medical devices, including the restrictions on promotional claims.
● Regulatory Inspections and Audits: Preparing for regulatory inspections and audits, including the documentation required and the handling of non-compliance.
● Vigilance and Recalls: Understanding the requirements for vigilance and recalls, including the reporting of serious incidents and the implementation of corrective actions.
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